It is well known to employ various intravascular endoprostheses delivered percutaneously for the treatment of diseases of various body vessels. These types of endoprosthesis are commonly referred to as stents. A stent is a generally formed longitudinal tubular device of biocompatible material, such as stainless steel, having holes or slots cut therein so they can be radially expanded, by a balloon catheter or the like, within the vessel. Stents are useful in the treatment of stenosis, strictures or aneurysms in body vessels such as blood vessels. These devices are implanted within the vessel to reinforce collapsing, partially occluded, weakened or abnormally dilated sections of a vessel. Stents are typically employed after angioplasty of a blood vessel to prevent restenosis of the diseased vessel. While stents are most notably used in blood vessels, stents may also be implanted in other body vessels such as the urogenital tract and bile duct.
Stents generally include an open flexible configuration. This configuration allows the stent to be inserted through curved vessels. Furthermore, the stent configuration allows the stent to be configured in a radially compressed state for intraluminal catheter implantation. Once properly positioned adjacent the damaged vessel, the stent is radially expanded so as to support and reinforce the vessel. Radial expansion of the stent can be accomplished by inflation of a balloon attached to the catheter. Examples of various stent constructions are shown in U.S. Pat. No. 4,733,665 filed by Palmaz on Nov. 7, 1985, which is hereby incorporated herein by reference.
However, such balloon expandable stents are often impractical for use in some vessels such as the carotid artery. The carotid artery is easily accessible from the exterior of the human body, and is often visible by looking at ones neck. A patient having a balloon expandable stent made from stainless steel or the like, placed in their carotid artery might be susceptible to sever injury through day to day activity. A sufficient force placed on the patients neck, such as by falling, could cause the stent to collapse, resulting in injury to the patient. In order to prevent this, self expanding stents have been proposed for use in such vessels. Self expanding stents act like springs and will recover to their expanded or implanted configuration after being crushed.
Many self-expanding stents employ the use of alloys such as Nitinol (Ni--Ti alloy) which have shape memory and/or superelastic characteristics in medical devices which are designed to be inserted into a patient's body. The shape memory characteristics allow the devices to be deformed to facilitate their insertion into a body lumen or cavity and then be heated within the body so that the device returns to its original shape. Superelastic characteristics on the other hand generally allow the metal to be deformed and restrained in the deformed condition to facilitate the insertion of the medical device containing the metal into a patient's body, with such deformation causing the phase transformation. Once within the body lumen the restraint on the superelastic member can be removed, thereby reducing the stress therein so that the superelastic member can return to its original un-deformed shape by the transformation back to the original phase.
Alloys having shape memory/superelastic characteristics generally have at least two phases. These phases are a martensite phase, which has a relatively low tensile strength and which is stable at relatively low temperatures, and an austenite phase, which has a relatively high tensile strength and which is stable at temperatures higher than the martensite phase.
Shape memory characteristics are imparted to the alloy by heating the metal at a temperature above which the transformation from the martensite phase to the austenite phase is complete, i.e. a temperature above which the austenite phase is stable (the Af temperature). The shape of the metal during this heat treatment is the shape "remembered." The heat treated metal is cooled to a temperature at which the martensite phase is stable, causing the austenite phase to transform to the martensite phase. The metal in the martensite phase is then plastically deformed, e.g. to facilitate the entry thereof into a patient's body. Subsequent heating of the deformed martensite phase to a temperature above the martensite to austenite transformation temperature causes the deformed martensite phase to transform to the austenite phase and during this phase transformation the metal reverts back to its original shape if unrestrained. If restrained, the metal will remain martensitic until the restraint is removed.
When stress is applied to a specimen of a metal such as Nitinol exhibiting superelastic characteristics at a temperature above which the austenite is stable (i.e. the temperature at which the transformation of martensite phase to the austenite phase is complete), the specimen deforms elastically until it reaches a particular stress level where the alloy then undergoes a stress-induced phase transformation from the austenite phase to the martensite phase. As the phase transformation proceeds, the alloy undergoes significant increases in strain but with little or no corresponding increases in stress. The strain increases while the stress remains essentially constant until the transformation of the austenite phase to the martensite phase is complete. Thereafter, further increases in stress are necessary to cause further deformation. The martensitic metal first deforms elastically upon the application of additional stress and then plastically with permanent residual deformation.
If the load on the specimen is removed before any permanent deformation has occurred, the martensitic specimen will elastically recover and transform back to the austenite phase. The reduction in stress first causes a decrease in strain. As stress reduction reaches the level at which the martensite phase transforms back into the austenite phase, the stress level in the specimen will remain essentially constant but substantially less than the constant stress level at which the austenite transforms to the martensite) until the transformation back to the austenite phase is complete, i.e. there is significant recovery in strain with only negligible corresponding stress reduction. After the transformation back to austenite is complete, further stress reduction results in elastic strain reduction. This ability to incur significant strain at relatively constant stress upon the application of a load and to recover from the deformation upon the removal of the load is commonly referred to as superelasticity or pseudoelasticity. It is this property of the material which makes it useful in manufacturing tube cut self-expanding stents. The prior art makes reference to the use of metal alloys having superelastic characteristics in medical devices which are intended to be inserted or otherwise used within a patient's body. See for example, U.S. Pat. No. 4,665,905 (Jervis) and U.S. Pat. No. 4,925,445 (Sakamoto et al.).
Recently, there has been a desire to place a covering of biocompatible material over expandable stents. The covering for the stent can provide many benefits. For example, the covered stent could act as a graft. Intraluminal vascular grafts can be used to repair aneurysmal vessels, particularly aortic arteries, by inserting an intraluminal vascular graft within the aneurysmal vessel so that the prosthetic withstands the blood pressure forces responsible for creating the aneurysm. In addition, due to the open nature of uncovered stents there is a tendency for the stent to permit passage of material through the body of the stent. Such material may include excessive cell or tissue growth (intimal hyperplasia), thrombus formations and plaque in vascular situations and tumors in the bile or urogenital tract. These materials may have a tendency to block or otherwise re-occlude the open vessel. While covers would prevent material from passing through the stent wall, the covering itself must be sufficiently flexible so as to permit crimping of the stent for delivery, and subsequent deployment of the stent thereafter. Furthermore, the cover must be sufficiently attached to the stent that it will not detached during delivery and deployment.
In the past, in order to achieve a covered stent that has the necessary flexibility and attachment, most prior art covered stents have been balloon expandable covered stents. One example of this is shown in U.S. Pat. No. 5,667,523 issued to Bynon et al. on Sep. 16, 1997, which is hereby incorporated herein by reference. The Bynon et al. reference discloses a dual supported intraluminal graft comprising a biocompatible flexible layer, such as Polytetrafluroethylene (PTFE), sandwiched between two balloon expandable stents. The ends of the PTFE graft are folded back onto the outer surface of the second structural support, thereby forming flaps.
However, the covered stent disclosed in the Bynon reference, has many disadvantages when the balloon expandable stents are replaced with self-expanding stents. The PTFE graft layer disclosed therein is not attached to the outer stent. Its position is maintained only by the force of the inner stent pressing against the outer stent. Because the outward force exerted by a self-expanding stent is typically not large, the graft material could slip and move relative to the stents, which could cause the device not to function optimally. In addition, the Bynon et al. reference discloses that the PTFE graft is placed between the stents, when the stents are in their crimped condition. However, due to the nature of self-expanding stents, the graft material has to placed within the stents while the stents are in their fully expanded condition. This raises the possibility of damaging the stents when they are crimped for implantation. Damaging the PTFE material could also cause the device to not function optimally.
Therefore, there has been a need to have a self-expanding covered stent which overcomes the disadvantages of the prior art covered stents. There has also been a further need for a method of manufacturing a self-expanding covered stent which overcomes the disadvantages of prior art manufacturing methods. The present invention provides such a solution.